my personal edition > hypertension > news


  E-Mail this DGNews to a colleague

DGNews

FDA Grants Marketing Approval For Benicar (Olmesartan Medoxomil) For Treatment Of Hypertension

NEW YORK, NY -- April 26, 2002 -- Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Benicar, a new treatment option for hypertension which is a member of the rapidly growing angiotensin II receptor blocker (ARB) class. Benicar was discovered and developed by Sankyo Pharma and Forest will be its long-term co-promotion partner in the United States. Benicar, which can be administered alone or in combination therapy with other antihypertensive agents, will be available in the U.S. in the first half of 2002.

Studies have shown that Benicar 20 mg once a day, the recommended starting dose, resulted in double-digit blood pressure reduction, lowering systolic blood pressure by an average of 15mm Hg* and diastolic blood pressure by an average of 12mm Hg. In these studies, patients receiving placebo had average reductions in systolic blood pressure of 5.6 mm Hg and in diastolic blood pressure of 6.2mm Hg. In clinical trials the only adverse event that occurred in more than 1 percent of patients treated with Benicar and more frequently than those receiving placebo was dizziness (3% vs 1%).

Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories, said: "We congratulate Sankyo on its approval of Benicar and are very pleased to have the opportunity to co-promote a drug we believe will make an important contribution to the treatment of hypertension. We believe that the clinical profile, which demonstrates excellent efficacy at the recommended starting dose along with a favorable side effect profile compared to placebo will be attractive to physicians as they determine their appropriate patient treatment regimen."

Mr. Solomon further stated, "With the launch of Benicar we look forward to expanding our presence in the hypertension market which we established several years ago with Tiazac(R), a diltiazem calcium channel blocker, and we also have a New Drug Application for lercanidipine, a dihydropyridine calcium channel blocker, discovered by Recordati of Milan, Italy under review at the FDA."

* mm Hg = millimeters of mercury-the standard for measuring blood pressure

Except for the historical information contained herein, this release contains forward looking statements that involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2001 and the quarterly report on Form 10-Q for the periods ended June 30, 2001, September 30, 2001 and December 31, 2001.


SOURCE Forest Laboratories, Inc.

E-Mail this DGNews to a colleague

To print, use this version